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Two Steps to EU Results Disclosure Compliance

Background

European Union regulations require the disclosure of clinical trial results for all studies within 12 months of study completion or within 6 months for paediatric trials. There are over 12,000 studies listed on the EMA’s trial register (EU CTR) that were conducted by biopharmaceutical companies and other industry sponsors for which results are due now.

However, nearly 25% of these completed trials are missing results. A further analysis shows that industry sponsors that have implemented a commercial clinical trial disclosure system have only about 8% of their results apparently missing, while sponsors without a disclosure system appear to be missing approximately 42% of their results records. While there are a few legitimate reasons why these records are not available, that ratio is high. To address this apparent non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance:

Step 1: Know your studies

All interventional studies conducted in the European Union since May of 2004, including some pediatric studies conducted elsewhere that are part of an EU PIP (paediatric investigation plan), are recorded on EU CTR. Many organizations struggle to produce a definitive list of trials that are their responsibility. For industry sponsors the challenge is often tracking studies associated with acquisitions, so we recommend creating a comprehensive list of all acquired products and businesses, as well as their acquisitions, at least back to 2004. As a final step to completing this internal trial register, search EU CTR using the names of all associated organizations to find associated clinical trials.

Tip: When searching EU CTR, remember to search for naming and spelling variations

Step 2: Take responsibility – Claim, Correct, Assess, Disclose

Using the comprehensive list of clinical trials for which your organization is responsible, contact EU CTR to claim these studies where necessary, or work with the original investigator. Next triage the studies:

Confirm that the study status and completion date on EU CTR is correct. If not, work with the local competent authorities to correct the records.

List any study that completed more than 12 months ago that does not yet have results posted in EU CTR (6 months if they have paediatric participants[1]).

For completed studies that are missing results verify whether the study status and end-of-trial date are correct and:

Disclose results immediately if the data are correct or if correcting the data means that results are still past due OR

Determine that results are never due if correcting the data means results are not required. Note: We recommend documenting this decision.

Limitations

Following this two-step process will significantly improve compliance. However, there are limitations:

It is not possible to search Phase 1 studies on the public site of EU CTR if there are no paediatric The primary source for these studies will be your organizations records.

While some information may be out of date on EU CTR, it may take time to correct because all changes must be made through the responsible national competent authority.

Some sponsors do not agree with the workarounds required to post specific results data on EU CTR, for example posting cross-over studies or where ‘n/a’ would be the appropriate response and therefore chose to withhold results disclosure until these issues are addressed.

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[1] The timing of results disclosure depends on when the study was conducted, please refer to the appropriate regulations for details.

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